Cancer Patient Care in Clinical Trials Sponsored by the National Cancer Institute: What Does It Cost?

Abstract

“What does it cost?” This has been the refrain reiterated with increasing intensity over the last decade on the issue of financial coverage of patient care for patient’s enrolled in clinical trials sponsored by the National Cancer Institute (NCI). In the past, the answer to this question, to the frustration of health care payers and providers, has been, “We don’t know.” In recent years, the financial coverage of patient care in clinical trials has become an urgent question because implicit subsidies available for support of clinical research in the past have been suppressed by various measures aimed at achieving global health care cost containment (1). The NCI, through its Office of Clinical Research Promotion, has been in the forefront of addressing this problem by negotiating agreements in principle and in practice with such organizations as Medicare and the American Association of Health Plans for coverage of patient care in clinical trials sponsored by the National Institutes of Health (NIH) (2). Legislation mandating coverage of patient care costs for specific cancer clinical trials has been enacted in Maryland, Rhode Island, and Georgia (3) and is under consideration in several other states. A similar mandate is also under consideration at the federal level as part of the proposed Patient’s Bill of Rights Act of 1998 (4). These proposals must be “costed out,” by such agencies at the Congressional Budget Office (5) as they are considered, and many of these proposals and agreements contain requirements for continued evaluation of the economic impact of clinical trial coverage as the programs go into effect (4–6). Until now, the entities responsible for “costing out” the financial impact of coverage proposals have had to operate in the absence of empiric information. Because predicting financial exposure into the future is always risky business, these analyses have tended to err on the high side. Now, with the data provided by Wagner et al. (7) in this issue of the Journal, it will be possible to begin to place more realistic and, as it turns out, lower ceilings on these estimates. What can we learn from this study? Wagner et al. (7) examined the patient care cost of 61 cancer patients enrolled in NCI-sponsored phase II or phase III clinical trials at the Mayo Clinic from 1988 through 1994 and compared these costs with the 61 “control” patients receiving standard care in Olmsted County, MN. The 61 control patients were carefully pairmatched with the clinical trial patients on the basis of age, sex, site of primary cancer, stage of cancer, date of diagnosis, and clinical trial eligibility. Total cumulative medical care costs, for each case and control patient, were tracked at 1 month, 3 months, 6 months, 1 year, and 5 years after the date of diagnosis. In the analysis of 5-year cumulative costs, statistical methods were used that take the effects of censoring into account. The study found that trial participants experienced only slightly higher costs compared with control patients and that this difference was not statistically significant. At 1 year after diagnosis, the average cost for trial enrollees was $24 645 compared with $23 964 for comparable patients receiving standard care. The respective costs at 5 years were $46 424 and $44 133. These results should be considered preliminary because of the small size of this study and the notoriously high variance of medical cost data (8), as can be seen in Fig. 1 of Wagner et al. (7). Nevertheless, the results of this study and other preliminary work presented at a NCI-sponsored symposium in July 1998 (9) strongly suggest that, until more definitive